510(k) K073352
K073352 is an FDA 510(k) premarket notification submitted by Weber Medical GmbH for the device "WEBERNEEDLE BASIC LASER". The FDA issued a decision of Substantially Equivalent on Aug 11, 2008. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 11, 2008
- Date Received
- Nov 29, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Lamp, Infrared, Therapeutic Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type
- 510(k) Exempt